KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
NCT ID: NCT03236246
Last Updated: 2021-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
206 participants
INTERVENTIONAL
2017-08-15
2019-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
KRX-0502 1 tablet thrice daily (TID) with meals
KRX-0502
Oral ferric citrate with meals
Group 2
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
KRX-0502
Oral ferric citrate with meals
Interventions
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KRX-0502
Oral ferric citrate with meals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hgb ≥8.5 g/dL and ≤11.5 g/dL
* Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
* Serum intact parathyroid hormone ≤600 pg/mL
Exclusion Criteria
* Intravenous (IV) iron administered within 4 weeks prior to Screening
* Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
* Blood transfusion within 4 weeks prior to Screening
18 Years
ALL
No
Sponsors
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Keryx Biopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Keryx Biopharmaceuticals
Locations
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Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States
California Institute of Renal Research
Chula Vista, California, United States
California Institute of Renal Research
El Centro, California, United States
California Institute of Renal Research
Poway, California, United States
Denver Nephrologists, P.C.
Denver, Colorado, United States
Miami Kidney Group
Miami, Florida, United States
Kidney and Hypertension Specialists of Miami, P.A.
Miami, Florida, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, United States
Renal Associates, LLC
Columbus, Georgia, United States
Research by Design, LLC
Chicago, Illinois, United States
South Mississippi Medical Research, LLC
Gulfport, Mississippi, United States
Clinical Research Consultants
Kansas City, Missouri, United States
Sierra Nevada Nephrology Consultants
Reno, Nevada, United States
Hypertension and Nephrology Association
Eatontown, New Jersey, United States
Division of Kidney/HTN Research
Great Neck, New York, United States
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
Eastern Nephrology Associates
Greenville, North Carolina, United States
Southeastern Nephrology Associates
Jacksonville, North Carolina, United States
Eastern Nephrology Associates
New Bern, North Carolina, United States
Southeastern Nephrology
Wilmington, North Carolina, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, United States
South Carolina Nephrology & Hypertension Center, Inc
Orangeburg, South Carolina, United States
Nephrology Associates, P.C.
Nashville, Tennessee, United States
Research Management, Inc.
Austin, Texas, United States
Research Management, Inc.
Austin, Texas, United States
P & I Clinical Research, LLC
Lufkin, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KRX-0502-402
Identifier Type: -
Identifier Source: org_study_id
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